Clinical and preclinical studies demonstrate ibrexafungerp’s broad-spectrum activity and potential to treat a range of serious and life-threatening fungal infections
JERSEY CITY, N.J., July 22, 2020 (GLOBE NEWSWIRE) — SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced the presentation of four posters at the American Society for Microbiology (ASM) Microbe 2020 held virtually from June through August. The posters, presented as part of the ASM Microbe Online 2020 Summer of Science program, now available online, highlight the potential clinical utility of ibrexafungerp. Ibrexafungerp is the first representative of a new class of antifungal agents called triterpenoids, which are broad-spectrum, fungicidal, and designated by the suffix “-fungerp”. Following the successful completion of its VANISH Phase 3 program, the Company plans to submit a new drug application (NDA) for ibrexafungerp as a treatment for vaginal yeast infections in the second half of this year, while advancing several late-stage programs for the treatment of life-threatening fungal infections in hospitalized patients.
“Fungal infections are increasingly common and often represent serious public health threats, yet there are limited treatment options. The clinical and preclinical studies presented at ASM Microbe 2020 highlight ibrexafungerp’s potential across a broad spectrum of fungal infections, including resistant strains,” said Marco Taglietti, M.D., Chief Executive Officer of SCYNEXIS. “As superbugs flourish and antifungal drug development dwindles, we remain committed to advancing ibrexafungerp, our novel antifungal, for patients in the hospital and community settings. The COVID-19 pandemic is a powerful reminder about the importance of continuous development of anti-infectives.”
|Title||Treatment Outcomes of Oral Ibrexafungerp in Patients with Severe Fungal Infections, Refractory to or Intolerant of Standard of Care Antifungals: Results from the Phase 3 FURI Study Second Interim Analysis|
|Session||Virtual 380 – CIV01 Clinical Studies of Adult Infectious Diseases including Epidemiology and Clinical Trials|
|Authors||N. Azie, D. Angulo|
|Highlights||An interim analysis of 21 patients from the Phase 3 clinical study evaluating ibrexafungerp for the treatment of patients intolerant to the standard of care treatment for Candida infections (FURI Study) found that treatment with oral ibrexafungerp showed significant clinical benefit in 81% of patients, with 12 (57%) patients achieving a complete or partial response and 5 (24%) patients with stable disease. (Read more…) [Link to study details]|
|Title||Delayed Initiation of the Novel Glucan Synthase Inhibitor, Ibrexafungerp, is Effective in a Murine Model of Invasive Candidiasis Caused by Candida Auris|
|Session||Virtual 320 – AAR03 Antifungal Resistance Epidemiology and Mechanisms|
|Authors||N. P. Wiederhold1, L. K. Najvar1, R. Jaramillo1, M. Olivo1, H. P. Patterson1, S. Barat2, K. Borroto-Esoda2, G. Catano1, T. F. Patterson1; 1UT Hlth.San Antonio, San Antonio, TX, 2SCYNEXIS, Inc., Jersey City, NJ|
|Highlights||An in vivo delayed initiation study of Candida auris in a murine model found that treatment with ibrexafungerp (40mg/kg) significantly improved survival and reduced fungal burden. These data further support the potential utility of ibrexafungerp as a treatment for invasive infections caused by Candida auris. [Link to study details]|
|Title||Determination of Antifungal Activity of SCY-078, a Novel Glucan Synthase Inhibitor, against a Broad Panel of Rare Pathogenic Fungi|
|Session||AAR03 Antifungal Resistance Epidemiology and Mechanisms|
|Authors||M. Ghannoum1, L. Long1, R. Sherif1, F. Z. Abidi1, K. Borroto-Esoda2, S. Barat2, D. Angulo3, N. Wiederhold4; 1Case Western Reserve Univ., Cleveland, OH, 2Scynexis, Inc., Jersey City, NJ, 3Scynexis, Jersey City, NJ, 4Univ. of Texas San Antonio, San Antonio, TX|
|Highlights||An in vitro study found that ibrexafungerp demonstrated potent activity against 13 different genera of rare fungal pathogens and effectiveness against 7 more, supporting its broad-spectrum activity and potential to treat a range of fungal pathogens. [Link to study details]|
|Title||Ibrexafungerp or Caspofungin in Combination with Azoles against Clinical Isolates of Aspergillus, Including Those Resistant to Azoles|
|Session||Virtual 335 – AAR08 New Antimicrobial Agents (in vitro and in vivo Studies Prior to the Start of Clinical Therapeutic Studies/Pre-phase 2) – In vitro and In vivo study of new antimicrobials|
|Authors||V. Jagadeesan1, E. Driscoll2, B. Hao2, S. Cheng2, S. Barat3, T. Chen4, K. Borroto-Esoda3, D. Angulo3, C. J. Clancy2, M. Nguyen2; 1Univ. of Pittsburgh Med. Ctr., Pittsburgh, PA, 2Univ. of Pittsburgh, Pittsburgh, PA, 3Scynexis Inc., Jersey City, NJ, 4Scynexis Inc., Jersey City, NJ|
|Highlights||An in vitro study evaluating the efficacy of ibrexafungerp (IBX) and caspofungin (CAS) alone or in combination with azole treatments against 50 Aspergillus clinical isolates found that the combination of IBX or CAS with azole treatment yielded synergistic activity. These results support further investigations evaluating the potential for the use of ibrexafungerp and azoles in combination for the treatment of infections caused by Aspergillus.
[Link to study details]
All posters will be available on the SCYNEXIS website in the near future via link.
Ibrexafungerp [pronounced eye-BREX-ah-FUN-jerp] is an investigational antifungal agent and the first representative of a new class of antifungal agents called triterpenoids, which are broad-spectrum, fungicidal, and designated by the suffix “-fungerp”. This agent combines the well-established activity of glucan synthase inhibitors with the potential flexibility of having oral and IV formulations. Ibrexafungerp is currently in development for the treatment of fungal infections caused primarily by Candida (including C. auris) and Aspergillus species. It has demonstrated broad spectrum antifungal activity, in vitro and in vivo, against multidrug-resistant pathogens, including azole- and echinocandin-resistant strains. The FDA has granted Qualified Infectious Disease Product (QIDP) and Fast Track designations for the formulations of ibrexafungerp for the indications of invasive candidiasis (IC) (including candidemia), invasive aspergillosis (IA) and vulvovaginal candidiasis (VVC) and has granted Orphan Drug Designation for the IC and IA indications. Ibrexafungerp is formerly known as SCY-078.
SCYNEXIS, Inc. (NASDAQ: SCYX) is a biotechnology company pioneering innovative medicines to help millions of patients worldwide overcome and prevent difficult-to-treat infections that are becoming increasingly drug-resistant. Our lead candidate, ibrexafungerp (formerly known as SCY-078), is a broad-spectrum, IV/oral antifungal agent representing a novel therapeutic class, in late stage development for multiple indications, ranging from vaginal yeast infections to life-threatening fungal infections in hospitalized patients. The SCYNEXIS team has deep expertise in anti-infective drug development and marketing, which can be leveraged to advance ibrexafungerp from clinical development to commercialization. For more information, visit www.scynexis.com.
Forward Looking Statement
Statements contained in this press release regarding expected future events or results are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited, to: risks inherent in SCYNEXIS’ ability to successfully develop and obtain FDA approval for ibrexafungerp; the expected costs of studies and when they might begin or be concluded; and SCYNEXIS’ reliance on third parties to conduct SCYNEXIS’ clinical studies. These and other risks are described more fully in SCYNEXIS’ filings with the Securities and Exchange Commission, including without limitation, its most recent Annual Report on Form 10-K under the caption “Risk Factors” and other documents subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. SCYNEXIS undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
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